Prior Authorization Consequences + Fast-Tracked FDA Approvals

Sarah Shelson  0:03  
Welcome to Healthcare Policy pop. I'm Sarah Shelson. It's Tuesday July 25 2023. Today's pop topics, policy experts and patients on the value of the accelerated approval pathway and prior authorization experiences that change lives for the worse. Let's start with accelerated approval. On Monday, patient's rising now hosted a hill briefing on accelerated approval, and its emphasis on getting new treatments to patients safely and quickly. Patients rising now just released a new report that details concerns around growing CMS coverage restrictions for this care. Here's McKay Jemison, who leads patients rising now speaking about the event. 

MacKay Jimeson  0:46  
Our ask is for lawmakers to really stand behind this program. This has been a successful program is one that's gotten treatments to patients as quickly as possible and something that needs to be sustained for future. 

Sarah Shelson  0:57  
You can find the full patients rising now report in the show notes.

Sarah Shelson  1:06  
Also speaking on the topic of accelerated approval is Terry Wilcox, founder and CEO of patients rising. In a recent Bloomberg Law article discussing the FDA is full approval of the Alzheimer's drug Leqembi  Wilcox says CMS is on a slippery slope. Quote, if CMS continues with these restrictions on accelerated approval drugs, patients will face even more challenges in accessing new treatments that could otherwise change their lives. A link to the article is in the show notes. Congressman John Joyce of Pennsylvania had similar themes in his remarks in a recent House Energy and Commerce Committee meeting. 

Congressman John Joyce  1:44  
I have said as a practicing physician and continue to say, as a member of this great legislative body that innovation is the cornerstone of American medicine. It is something that patients expect and we meet to make sure that government policy is not a barrier to access to the latest technology and therapies. 

Sarah Shelson  2:06  
The issue of access to accelerated approval treatments remains a concern among patients in the chronic and rare disease communities. We'll continue to track this in upcoming episodes.

Sarah Shelson  2:16  
Also today, a new survey by morning consult for the American Hospital Association shows that more than three out of five patients have had care delayed because of their insurer in the past two years, and nearly half say their health worsened as a result. Jody Quinn a patient from Massachusetts 13th congressional district who lives with psoriatic disease experienced this firsthand, she tells us prior authorization led to long term joint damage after her treatment was denied three times. Even the denial process was painstakingly long. 

Jody Quinn  2:56  
This took months of getting it through, you know when you get every excuse in the book, that person is on vacation, the fax machine was out of paper, we can't find it. It didn't send it through. So it was many months. And in that time, I had no protection. So I suffered some joint damage. And also I had to go to my employer and say I can't work five days a week. It's just too painful. So I cut down to four. We eventually got on an alternate treatment. However, I still have never returned back to work full time. I still only work four days a week. So that was my most devastating story. And oddly enough, I'm going through the process again right now. And it's a different situation. That was always what my rheumatologist this was my primary care. Quinn says the prior authorization process is delayed at so many junctures. Quinn wants policy to address this. I think it would have to be made part of the legislative process that, you know, prior authorization from beginning to end has to have a 72 hour not just from the insurance company. It has to be from the doctor's office straight through. So I guess maybe legislature you have to be rewritten to say, you know from when the prescriptions written until the denial that has to be all included, not just when it's finally submitted for approval. 

Sarah Shelson  4:10  
You can find more stories like Quinn's in the show notes. And finally today, the patient's rising community will observe the 33rd anniversary of the Americans with Disabilities Act tomorrow, July 26. Today, 61 million Americans live with a disability. That's every one in four adults who benefit from the equal opportunity that this landmark legislation provides. That's all for today. We're back on Thursday for another health care policy pop a resource of patients rising now. I'm Sarah Shelson, have a great day.